Food Insecurity, Food as Medicine, Hypertension

Part of paid clinical trials in Floyd, Kentucky.

Sponsor
Alison Gustafson
Study ID
NCT07011251
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Food as Medicine Program — BEHAVIORAL
    Grocery Prescription - participants will receive a card loaded with $100 per month to be used on the Instacart Fresh Funds program website/app or a SodaHealth grocery prescription card to be used inside a Kroger or Food City stores. Patients who select grocery delivery where Instacart is not available will receive Food City meals for the same value. or 2) Medically Tailored Meals (MTM) - participants receive approximately 5 frozen meals per week from Mom's Meals that follow an approved diet for those with hypertension. Participants will complete screening questions (screening decision tree attached) after informed consent to determine which food package the participant will receive. The screening decision tree is a tool that asks about kitchen availability for preparing foods, skills, and access to transportation. Depending on how the patient answers they will receive either grocery prescription or MTM for 3-months or 12-weeks.
  • Survey — OTHER
    Participants answering "no" to assistance but agreeing to the 20-30 minute survey will receive a direct link to a survey related to reasons for not wanting assistance to answer questions at one time point.

Study Details

Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.

Key Dates

Start date
Aug 16, 2024
Status verified
Mar 2026
Primary completion
Jan 29, 2025
Completion
Jan 29, 2025

Study Design

Enrollment
159 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Food is Medicine Program Type
    Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey.

Primary Outcome Measure

Change Systolic Blood Pressure [ Time Frame: Baseline and week 12 ]

Locations (1)

FacilityCityStateZIP
Appalachian Regional HealthcareFloydKentucky41601

Find similar trials in Floyd, KY

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Appalachian Regional Healthcare· Floyd, KY

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